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Recall Observatory FDA recall evidence

Drug product

Burkhart topical anesthetic gel, benzocaine 20 %, Strawberry Flavor, 1 oz (30 mL), Manufactured for Burkhart Dental Supply, Tacoma, Washington, 98409. NDC: 43498-310-30

D-0603-2026

May 21, 2026

Class II

Product summary

Firm
Keystone Industries
Event
Event 99076
Status
Ongoing
Classification
Class II
Quantity
150 units
Official record key
drug-enforcement:D-0603-2026

Official wording

Reason: Defective container:may contain bottles with incomplete seals

Code information: BNZ-001917, Exp 04/15/2029

Distribution pattern: Nationwide in the USA

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Defective container:may contain bottles with incomplete seals